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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000001701
Receipt No. R000002048
Scientific Title Combined therapy of radiofrequency ablation with intratumoral dendritic cell infusion for hepatocellular carcinoma: clinical safety
Date of disclosure of the study information 2012/04/01
Last modified on 2020/08/20

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Basic information
Public title Combined therapy of radiofrequency ablation with intratumoral dendritic cell infusion for hepatocellular carcinoma: clinical safety
Acronym Combined therapy of radiofrequency ablation with intratumoral dendritic cell infusion for hepatocellular carcinoma: clinical safety
Scientific Title Combined therapy of radiofrequency ablation with intratumoral dendritic cell infusion for hepatocellular carcinoma: clinical safety
Scientific Title:Acronym Combined therapy of radiofrequency ablation with intratumoral dendritic cell infusion for hepatocellular carcinoma: clinical safety
Region
Japan

Condition
Condition Hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Safety
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine Vaccine
Interventions/Control_1 Immature dendritic cell treatment
Interventions/Control_2 OK-432 stimulated dendritic cell treatment
Interventions/Control_3 No cell treatment control
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Advanced hepatocellular carcinoma
Key exclusion criteria Immunodeficiency
Target sample size 36

Research contact person
Name of lead principal investigator
1st name Shuichi
Middle name
Last name Kaneko
Organization Kanazawa University
Division name Graduate school of medicine
Zip code 920-8641
Address 13-1 Takara-machi, Kanazawa, Ishikawa, Japan
TEL 076-265-2235
Email s-kaneko@umin.ac.jp

Public contact
Name of contact person
1st name Tatsuya
Middle name
Last name Yamashita
Organization Kanazawa University
Division name University hospital
Zip code 920-8641
Address 13-1 Takara-machi, Kanazawa, Ishikawa, Japan
TEL 0762652235
Homepage URL
Email ytatsuya@m-kanazawa.jp

Sponsor
Institute Kanazawa University
Institute
Department

Funding Source
Organization Kanazawa University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kanazawa University Hospital
Address 13-1 Takara-machi, Kanazawa, Ishikawa, Japan
Tel 076-265-2000
Email ytatsuya@m-kanazawa.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2012 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2009 Year 01 Month 28 Day
Date of IRB
Anticipated trial start date
2009 Year 02 Month 01 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 02 Month 10 Day
Last modified on
2020 Year 08 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002048

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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